AzTrials
AzTrials

OSANCT05060133

Changes of the Upper Airway Volume After Orthognathic Surgery

An observational study of OSA and Malocclusion, run by Lund University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of the present project is to analyze the impact from orthognathic surgery on the upper airway respiratory volume. The primary objective is comparison of differences in the in the airway changes due to maxillary movements and mandibular movements. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
OSA, Malocclusion, Dentofacial Deformities
What is being tested?
Orthognathic Surgery
Type of treatment
Surgery or procedure
How many people
62 participants
Where
1 siteSweden
Study dates
15 May 2021to 28 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Consecutive patients, aged between 18 to 30 years, with diagnosed maxillary retrognatism and Angle class III occlusion deviating at least 5 mm in sagittal and/or vertical aspects from normal occlusion

Who may be able to join

  • Maxillary retrognatism and Angle class III occlusion deviating at least 5 mm in sagittal and/or vertical aspect from normal occlusion measured as interincisal distance
  • Age between 18 to 30 years

Who cannot join

  • Systemic diseases in the musculoskeletal apparatus
  • Drug abuse
  • Poor psychic status
  • Disease in the temporomandibular joint

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Dept Oral and Maxillofacial Surgery

    Lund, 22185

Other trials in Sweden

About this study

Official title: Changes of the Upper Airway Volume After Orthognathic Surgery - is This a Treatment Option of Severe Obstructive Sleep Apnea?

The aim of the present project is to analyze the impact from orthognathic surgery on the upper airway respiratory volume.

The primary objective is comparison of differences in the in the airway changes due to maxillary movements and mandibular movements.

Secondary objectives are the analysis of any correlation between the magnitude of the movement and the airway volume, correlation between the direction of the movements and the changes in airway volume and correlation with Health-Related Quality of Life (HRQoL). Expected confounding factors like smoking habits and Body Mass Index (BMI) will be analyzed.

Read the detailed description

Background Orthognathic surgery affects the position of the teeth and jaws. The upper airway compartment is in close approximation to these tissues. Consequently, changes of the respiratory volume after surgical treatment in this region is expected.

Orthognathic surgery The correction of severe malocclusions and dentofacial deformities has since the beginning of 20th century been treated with orthodontic and surgical methods. Epidemiologic surveys reveal that about 5 % of the western population has dentofacial disproportions of a magnitude that affect both function and facial aesthetics.

Respiratory disability Obstructive sleep apnea, estimated to occur in between 5% and 10% of the western countries' population. Disabilities in the upper airway may affect the patient's general health and quality of life. Breathing incapability often lead to impaired sleep and consequently decrease the individual's overall capacity and performance. Known predisposing factors are obesity, smoking and age.

Treatment of respiratory disabilities Medical, behavioral and surgical treatment options are prospected methods and the treatment is individually planned in detail. The complex nature of obstructive sleep apnea may require multidisciplinary assessment.

Orthognathic surgery as treatment for obstructive sleep apnea syndrome (OSAS) Correction of anatomical abnormalities may cure obstructive sleep apnea or improve compliance with positive airway pressure treatment. Orthognathic surgery with an anterior movement of the jaws can increase the airway volume and facilitate breathing.

Measurements and evaluation of the upper airway volume Different methods of measuring the upper airway, like physio metric and radiological are present.

Project plan Subjects The study is performed retrospectively on a prospective material. Sixty-two consecutive patients aged between 18 to 30 years with Angle class III occlusion were included in the study.

Patients with systemic diseases in the musculoskeletal apparatus, drug abuse, poor psychic status or disease in the temporomandibular joint were excluded from the study.

Methods The study is performed retrospectively on a prospective material. Examination with clinical examination, BMI, HRQoL questionnaire, dental casts, photography and two- and three-dimensional radiographs and cephalometric measures was performed prior to surgery.

The patient's data (x-ray and photographs) were linked together in computer software programs and used for cephalometric analysis and simulation of the orthodontic and surgical movements (Fasad® and Simplant® PRO 12.00 OMS). The treatment was performed in accordance with this plan.

The last follow up was performed 12 months after surgery including identical registrations as prior to surgery, described above. HRQoL questionnaires consisted of Oral Health Impact Profile (OHIP-S), Jaw Functional Limitation Scale (JFLS-20) and Orofacial Aesthetic Scale (OAS-S). The results from the presurgical questionnaire will be compared with the postsurgical results. Twenty subjects were asked to fill in the follow-up questionnaire twice with two weeks interval for a reliability test of the method.

The pre- and postoperative CT will be compared in a software for measurements of upper airway volume with the software Philips IntelliSpace® Portal, version 11. Measures will be performed with an divided analysis of the upper airway according to the method described by Kim. Thus, the upper airway segmented into four compartments. The measurements will be performed on the sole segment volume and the total airway volume. A comparison of jaw movements, changes in airway volume, BMI and HRQoL will be performed.

Statistical methods The sample size, 62 patients, was based on numbers included in previous similar studies from other centers.

Simple statistics, mean and standard deviation (SD), for all variables will be used. Differences in airway volume and movements, preoperatively and postoperatively will be compared with McNemar's-test. Wilcoxon's paired-sample test will be used for analyzing airway volume before and after surgery as a numeric variable. The reliability test, performed as a test-retest, will be analyzed with the intraclass correlation coefficient, Fisher's test for pair comparisons and Pearson's correlation coefficient. Mann-Whitney-test will be performed to detect differences between questionnaire responses and clinical findings, i.e. BMI, and volumetric findings. The data will be assessed by using Spearman correlation analysis and simple linear regression analysis. Two-sided tests and alpha level 0.05 will be used. Confidence interval (CI) will be calculated. For all computations IBM® SPSS® statistical software will be used.

Being tested
Orthognathic Surgery
Medical subject headings
Malocclusion, Dentofacial Deformities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orthognathic SurgeryProcedure or surgery

    Surgical corrections of dentofacial deformities and malocclusions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in upper airway volume

    Measurements in three dimensional radiographs from pre- and postoperative recordings.

    Measured: Preoperative and 12 months postoperative follow up.

Secondary outcomes (2)
  1. Correlation BMI and upper airway volume.

    Correlation between changes in Upper airway volume and Body mass index (BMI).

    Measured: Preoperative and 12 months postoperative follow up.

  2. Direction of surgical movements

    Correlation between the direction of the surgical movements and the changes of the upper airway volume.

    Measured: Preoperative and 12 months postoperative follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2021
  2. Study start15 May 2021
  3. Primary completion31 Aug 2022
  4. Study completion28 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05060133
Sponsor's protocol ID
OFRS939554
Status last verified
Jan 2023
First submitted
13 Sep 2021
Last updated
30 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baldwin CM, Griffith KA, Nieto FJ, O'Connor GT, Walsleben JA, Redline S. The association of sleep-disordered breathing and sleep symptoms with quality of life in the Sleep Heart Health Study. Sleep. 2001 Feb 1;24(1):96-105. doi: 10.1093/sleep/24.1.96.

    PubMed 11204058
  • Moscarino S, Kotter F, Brandt M, Modabber A, Kniha K, Holzle F, Wolf M, Mohlhenrich SC. Influence of different surgical concepts for moderate skeletal class II and III treatment on the nasopharyngeal airway space. J Craniomaxillofac Surg. 2019 Oct;47(10):1489-1497. doi: 10.1016/j.jcms.2019.07.006. Epub 2019 Jul 18.

    PubMed 31399294
  • Kim JS, Kim JK, Hong SC, Cho JH. Pharyngeal airway changes after sagittal split ramus osteotomy of the mandible: a comparison between genders. J Oral Maxillofac Surg. 2010 Aug;68(8):1802-6. doi: 10.1016/j.joms.2009.11.010. Epub 2010 May 26.

    PubMed 20537778
  • Kim YJ, Hong JS, Hwang YI, Park YH. Three-dimensional analysis of pharyngeal airway in preadolescent children with different anteroposterior skeletal patterns. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):306.e1-11; discussion 306-7. doi: 10.1016/j.ajodo.2009.10.025.

    PubMed 20197163
  • Bengtsson M, Wall G, Greiff L, Rasmusson L. Treatment outcome in orthognathic surgery-A prospective randomized blinded case-controlled comparison of planning accuracy in computer-assisted two- and three-dimensional planning techniques (part II). J Craniomaxillofac Surg. 2017 Sep;45(9):1419-1424. doi: 10.1016/j.jcms.2017.07.001. Epub 2017 Jul 12.

    PubMed 28800842
  • Bengtsson M, Wall G, Miranda-Burgos P, Rasmusson L. Treatment outcome in orthognathic surgery - A prospective comparison of accuracy in computer assisted two and three-dimensional prediction techniques. J Craniomaxillofac Surg. 2018 Nov;46(11):1867-1874. doi: 10.1016/j.jcms.2017.01.035. Epub 2017 Feb 13.

    PubMed 28318923
  • Pellby D, Bengtsson M. Do Patients Detect Changes in Breathing After Orthognathic Surgery? J Oral Maxillofac Surg. 2024 Jan;82(1):36-46. doi: 10.1016/j.joms.2023.09.017. Epub 2023 Sep 27.

    PubMed 37858599

Questions about this trial

What is this clinical trial studying?

An observational study of OSA and Malocclusion, run by Lund University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in upper airway volume (time frame: Preoperative and 12 months postoperative follow up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05060133, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in